None listed
Conditions
Brief summary
Women enrolled in the National Cervical Screening Programme (NCSP) present for regular cervical smears (cytology) to screen for early cervical abnormalities (precancer). Nearly all cervical cancers are now known to be caused by certain types of human papillomavirus (high risk human papillomavirus, hrHPV). In 2009 New Zealand introduced an HPV immunisation program for young women against the 2 most common HPV types. Cervical screening is currently a cost effective intervention in New Zealand, but this will become progressively less so as HPV immunisation uptake increases. Changes to the NCSP will be required to improve cost effectiveness in the context of HPV immunisation, but any such changes cannot be made without evaluation of new technologies and processes. Overseas studies have shown that primary HPV screening is more sensitive in detecting precancerous lesions than cytology, can be performed less frequently, is more costeffective in countries with an HPV immunization program, such as NZ and may require fewer colposcopy referrals. Several developed countries are moving to implement or pilot hrHPV testing,. This project will examine the use of HPV as a primary screening test over a one year period with respect to: 1. Acceptability of the change to women 2. Changes to the NZ Cervical Screening Guidelines 3. Education of colposcopists, GPs and nurses about HPV testing in respect to interpretation of results, referral and management of women with abnormal results 4. Laboratory processing of specimens including time and motion studies 5. Requirements for associated information technology changes including to the NCSP register The study has some similarities to a larger Australian study, conducted by the University of New South Wales and Victorian Cytology Service, which will test 5000 women. For some analyses, results will be pooled with the Australian study
Interventions
Intervention (Arm 2): The HPV test will be the primary test performed on a cervical smear sample that is taken in the usual manner and stored in the Thin-Prep liquid-based storage fluid. If the participant tests positive for oncogenic HPV other than types 16/18, a cytology test is the triage. (The HPV test will be undertaken only once in each patient and the test duration is around 15 minutes) Intervention (Arm 3): HPV screening with types 16/18 genotyping and dual-stained (DS) cytology triage of intermediate risk women with other oncogenic HPV infection. The HPV test will be the primary test performed on a cervical smear sample that is taken in the usual manner and stored in the Thin-Prep liquid-based storage fluid. The triage for other oncogenic HPV positive women is a dual-stained cytology sample for the detection of more advanced HPV infection. (The HPV test will be undertaken only once in each patient and the test duration is around 15 minutes)
Sponsors
Study design
Eligibility
Inclusion criteria
1. Eligible women attending for routine cervical screening who have their smears collected in primary care and sent to DML for assessment 2. Women between the ages of 25 to 64 years
Exclusion criteria
1. who have had a total hysterectomy 2. with signs and symptoms suggestive of cervical cancer 3. currently undergoing treatment for cervical pre-cancer or cancer 4. attending follow-up of a prior cervical abnormality and have not yet been discharged to routine screening 5. known to be pregnant